Biopsy targeting cube with living hinges

ABSTRACT

A biopsy system comprises a control module, a localization assembly, a biopsy device, and a targeting cube. The biopsy device comprises a holster portion and a probe. The probe and/or other associated components are configured to selectively couple with a targeting cube, where the targeting cube is configured to selectively couple with a grid plate having apertures for receiving the targeting cube. The targeting cube comprises a body defined by faces. The targeting cube further comprises guide holes that originate and terminate at the faces and pass through the body of the targeting cube to provide passageways through the targeting cube. The targeting cube further comprises at least one hinged member positioned along the outer portion of the targeting cube and interfacing with an aperture in the grid plate. The hinged member may provide a tapered profile to the targeting cube and may further comprise an elastomeric portion.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in variousmedical procedures using a variety of devices. Biopsy devices may beused under stereotactic guidance, ultrasound guidance, MRI guidance, PEMguidance, BSGI guidance, or otherwise. Merely exemplary biopsy devicesare disclosed in U.S. Pat. No. 6,273,862, entitled “Surgical Device forthe Collection of Soft Tissue,” issued Aug. 14, 2001; U.S. Pat. No.6,231,522, entitled “Biopsy Instrument with Breakable Sample Segments,”issued May 15, 2001; U.S. Pat. No. 6,228,055, entitled “Devices forMarking and Defining Particular Locations in Body Tissue,” issued May 8,2001; U.S. Pat. No. 6,120,462, entitled “Control Method for an AutomatedSurgical Biopsy Device,” issued Sep. 19, 2000; U.S. Pat. No. 6,086,544,entitled “Control Apparatus for an Automated Surgical Biopsy Device,”issued Jul. 11, 2000; U.S. Pat. No. 6,077,230, entitled “BiopsyInstrument with Removable Extractor,” issued Jun. 20, 2000; U.S. Pat.No. 6,017,316, entitled “Vacuum Control System and Method for AutomatedBiopsy Device,” issued Jan. 25, 2000; U.S. Pat. No. 6,007,497, entitled“Surgical Biopsy Device,” issued Dec. 28, 1999; U.S. Pat. No. 5,980,469,entitled “Method and Apparatus for Automated Biopsy and Collection ofSoft Tissue,” issued Nov. 9, 1999; U.S. Pat. No. 5,964,716, entitled“Method of Use for a Multi-Port Biopsy Instrument,” issued Oct. 12,1999; U.S. Pat. No. 5,928,164, entitled “Apparatus for Automated Biopsyand Collection of Soft Tissue,” issued Jul. 27, 1999; U.S. Pat. No.5,775,333, entitled “Apparatus for Automated Biopsy and Collection ofSoft Tissue,” issued Jul. 7, 1998; U.S. Pat. No. 5,769,086, entitled“Control System and Method for Automated Biopsy Device,” issued Jun. 23,1998; U.S. Pat. No. 5,649,547, entitled “Methods and Devices forAutomated Biopsy and Collection of Soft Tissue,” issued Jul. 22, 1997;U.S. Pat. No. 5,526,822, entitled “Method and Apparatus for AutomatedBiopsy and Collection of Soft Tissue,” issued Jun. 18, 1996; U.S. Pub.No. 2008/0214955, entitled “Presentation of Biopsy Sample by BiopsyDevice,” published Sep. 4, 2008; U.S. Pub. No. 2007/0255168, entitled“Grid and Rotatable Cube Guide Localization Fixture for Biopsy Device,”published Nov. 1, 2007; U.S. Pub. No. 2007/0118048, entitled “RemoteThumbwheel for a Surgical Biopsy Device,” published May 24, 2007; U.S.Pub. No. 2005/0283069, entitled “MRI Biopsy Device LocalizationFixture,” published Dec. 22, 2005; U.S. Pub. No. 2003/0199753, entitled“MRI Compatible Biopsy Device with Detachable Probe,” published Oct. 23,2003; U.S. Pub. No. 2003/0109803, entitled “MRI Compatible SurgicalBiopsy Device,” published Jun. 12, 2003; U.S. Provisional PatentApplication Ser. No. 60/874,792, entitled “Biopsy Sample Storage,” filedDec. 13, 2006; and U.S. Provisional Patent Application Ser. No.60/869,736, entitled “Biopsy System,” filed Dec. 13, 2006. Thedisclosure of each of the above-cited U.S. patents, U.S. PatentApplication Publications, and U.S. Provisional Patent Applications isincorporated by reference herein.

Some biopsy systems may provide an apparatus to guide a probe and/orother components of a biopsy device to a desired biopsy site. In somesuch biopsy systems, a guide cube and positioning grid plate may beused. The guide cube may be selectively located within an opening in thegrid plate. The guide cube may include guide holes to receive a portionof the probe and/or other components, for example a needle, cannula,obturator, or combinations of these or other components. With the guidecube inserted in the grid plate, the probe or other components can beguided through a selected guide hole of the guide cube to arrive at adesired biopsy site. The desired biopsy site may or may not have beenidentified and/or targeted by one or more of the guidance approachesmentioned above. In some situations, it might be desirable to provide aguide cube with features that improve a guide cube's use with one ormore positioning grid plates.

While several systems and methods have been made and used for obtaininga biopsy sample, it is believed that no one prior to the inventors hasmade or used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings. Inthe drawings, like numerals represent like elements throughout theseveral views.

FIG. 1 is a perspective view of a biopsy system including a controlmodule remotely coupled to a biopsy device, and including a localizationassembly.

FIG. 2 is a perspective view of a breast coil of the localizationassembly of FIG. 1.

FIG. 3 is a perspective view of the biopsy device inserted through theguide cube of the localization assembly of FIG. 1.

FIG. 4 is a perspective view of the obturator and cannula of the biopsysystem of FIG. 1.

FIG. 5 is an exploded perspective view of the obturator and cannula ofFIG. 4.

FIG. 6 is a perspective view of the guide cube inserted into the gridplate of the localization assembly of FIG. 1.

FIG. 7 is a perspective view of the obturator and cannula of FIG. 4 witha depth stop device of FIG. 1 inserted through the guide cube and gridplate of FIG. 6.

FIG. 8 is a perspective view of the guide cube of the biopsy system ofFIG. 1.

FIG. 9 is a diagram of nine guide positions achievable by rotating theguide cube of FIG. 8.

FIG. 10 is a perspective view of another guide cube for the biopsysystem of FIG. 1 with a self-grounding feature.

FIG. 11 is a perspective view of the obturator and cannula of FIG. 1inserted into one of two guide cubes of FIG. 10 inserted into the gridplate of FIG. 1.

FIG. 12 is a perspective view of another guide cube having an open topand bottom with another self-grounding feature.

FIG. 13 is a rear perspective view of another guide cube with anotherself-grounding feature.

FIG. 14 is a front perspective view of the guide cube of FIG. 13.

FIG. 15 is a right side view of the guide cube of FIG. 13 with angled,parallel guide holes depicted in phantom.

FIG. 16 is a front perspective view of another guide cube havingelastomeric edges.

FIG. 17 is a rear perspective view of the guide cube of FIG. 16.

FIG. 18 is a perspective view of another guide cube having anelastomeric body and nine expanding access slits for receiving a portionof a biopsy device.

FIG. 19 is a perspective view of another guide cube having anelastomeric body and nine expanding access star-shaped openings forreceiving a portion of a biopsy device.

FIG. 20 is a perspective view of another guide cube having anelastomeric body and three reduced sized guide holes that incorporatefeatures that may expand to accommodate a portion of a biopsy device.

FIG. 21 is a perspective view of another guide cube having anelastomeric body and three reduced sized star-shaped guide holes thatmay expand to accommodate a portion of a biopsy device.

FIG. 22 is a perspective view of another guide cube having anelastomeric body and malleable members adjacent and parallel to guideholes of the guide cube.

FIG. 23 is a top cross-section view of the guide cube of FIG. 22 takenalong line 23-23 shown in FIG. 22.

FIG. 24 is a perspective view of another guide cube having a pair oftapered sides.

FIG. 25 is a side cross-sectional view of the guide cube of FIG. 24,showing the guide holes in phantom.

FIG. 26 is a perspective view of another guide cube having a set ofelastomeric bumps that provide a taper profile to the guide cube.

FIG. 27 is a side view of the guide cube of FIG. 26.

FIG. 28 is a side view of another guide cube having hinge membersextending along a pair of sides and showing a central guide hole inphantom.

FIG. 29 is a front view of the guide cube of FIG. 28.

FIG. 30 is a front view of the guide cube of FIG. 28 inserted into agrid plate, with the grid plate shown partially.

FIG. 31 is side view of the guide cube and grid plate of FIG. 30,showing the grid plate in a cross-section taken along line 31-31 of FIG.30 and showing the central guide hole of the guide cube in phantom.

DETAILED DESCRIPTION

The following description of certain examples should not be used tolimit the scope of the present invention. Other features, aspects, andadvantages of the versions disclosed herein will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out theinvention. As will be realized, the versions described herein arecapable of other different and obvious aspects, all without departingfrom the invention. Accordingly, the drawings and descriptions should beregarded as illustrative in nature and not restrictive.

As shown in the figures, an exemplary magnetic resonance imaging (MRI orMR imaging) compatible biopsy system may include a control module (12),localization assembly (15), and biopsy device (14). In particular,localization assembly (15) is configured to localize a patient's breastand guide needle (90) of biopsy device (14) to a targeted area withinthe patient's breast; while control module (12) is operable to controlbiopsy device (14) after needle (90) has been introduced to the targetsite. These components and their sub-components will be discussedfurther below. In addition, guide cubes for use with variouslocalization assemblies will be discussed. While this disclosure mayreference the biopsy system as compatible with MRI and MRI equipment anddevices, it should be appreciated that other imaging techniques andequipment and devices may be used with the components described below,including but not limited to stereotactic, ultrasound, PEM, BSGI, and/orother imaging techniques and equipment.

I. Control Module

In FIGS. 1-3, MRI compatible biopsy system (10) has control module (12)that may be placed outside of a shielded room containing an MRI machine(not shown) or at least spaced away to mitigate detrimental interactionwith its strong magnetic field and/or sensitive radio frequency (RF)signal detection antennas. As described in U.S. Pat. No. 6,752,768,which is hereby incorporated by reference in its entirety, a range ofpreprogrammed functionality may be incorporated into control module (12)to assist in taking tissue samples. Control module (12) controls andpowers biopsy device (14) that is used with localization assembly (15).Biopsy device (14) is positioned and guided by localization fixture (16)attached to breast coil (18) that may be placed upon a gantry (notshown) of a MRI or other imaging machine.

In the present example, control module (12) is mechanically,electrically, and pneumatically coupled to biopsy device (14) so thatcomponents may be segregated that need to be spaced away from the strongmagnetic field and the sensitive RF receiving components of a MRImachine. Cable management spool (20) is placed upon cable managementattachment saddle (22) that projects from a side of control module (12).Wound upon cable management spool (20) is paired electrical cable (24)and mechanical cable (26) for communicating control signals and cutterrotation/advancement motions respectively. In particular, electrical andmechanical cables (24, 26) each have one end connected to respectiveelectrical and mechanical ports (28, 30) in control module (12) andanother end connected to holster portion (32) of biopsy device (14).Docking cup (34), which may hold holster portion (32) when not in use,is hooked to control module (12) by docking station mounting bracket(36). It should be understood that such components described above asbeing associated with control module (12) are merely optional.

Interface lock box (38) mounted to a wall provides tether (40) tolockout port (42) on control module (12). Tether (40) is uniquelyterminated and of short length to preclude inadvertent positioning ofcontrol module (12) too close to a MRI machine or other machine. In-lineenclosure (44) may register tether (40), electrical cable (24) andmechanical cable (26) to their respective ports (42, 28, 30) on controlmodule (12).

Vacuum assist is provided by first vacuum line (46) that connectsbetween control module (12) and outlet port (48) of vacuum canister (50)that catches liquid and solid debris. Tubing kit (52) completes thepneumatic communication between control module (12) and biopsy device(14). In particular, second vacuum line (54) is connected to inlet port(56) of vacuum canister (50). Second vacuum line (54) divides into twovacuum lines (58, 60) that are attached to biopsy device (14). Withbiopsy device (14) installed in holster portion (32), control module(12) performs a functional check. Saline may be manually injected intobiopsy device (14) or otherwise introduced to biopsy device (14), suchas to serve as a lubricant and to assist in achieving a vacuum sealand/or for other purposes. Control module (12) actuates a cuttermechanism (not shown) in biopsy device (14), monitoring full travel of acutter in biopsy device (14) in the present example. Binding inmechanical cable (26) or within biopsy device (14) may optionallymonitored with reference to motor force exerted to turn mechanical cable(26) and/or an amount of twist in mechanical cable (26) sensed incomparing rotary speed or position at each end of mechanical cable (26).

Remote keypad (62), which is detachable from holster portion (32),communicates via electrical cable (24) to control panel (12) to enhanceclinician control of biopsy device (14) in the present example,especially when controls that would otherwise be on biopsy device (14)itself are not readily accessible after insertion into localizationfixture (16) and/or placement of control module (12) is inconvenientlyremote (e.g., 30 feet away). However, as with other components describedherein, remote keypad (62) is merely optional, and may be modified,substituted, supplemented, or omitted as desired. In the presentexample, aft end thumbwheel (63) on holster portion (32) is also readilyaccessible after insertion to rotate the side from which a tissue sampleis to be taken.

Of course, the above-described control module (12) is merely oneexample. Any other suitable type of control module (12) and associatedcomponents may be used. By way of example only, control module (12) mayinstead be configured and operable in accordance with the teachings ofU.S. Pub. No. 2008/0228103, entitled “Vacuum Timing Algorithm for BiopsyDevice,” published Sep. 18, 2008, the disclosure of which isincorporated by reference herein. As another merely illustrativeexample, control module (12) may instead be configured and operable inaccordance with the teachings of U.S. patent application Ser. No.12/337,814, entitled “Control Module Interface for MRI Biopsy Device,”filed Dec. 18, 2008, the disclosure of which is incorporated byreference herein. Alternatively, control module (12) may have any othersuitable components, features, configurations, functionalities,operability, etc. Other suitable variations of control module (12) andassociated components will be apparent to those of ordinary skill in theart in view of the teachings herein.

II. Localization Assembly

Localization assembly (15) of the present example comprises breast coil(18) and localization fixture (16). These components of localizationassembly (15) are described further below.

Left and right parallel upper guides (64, 66) of localization framework(68) are laterally adjustably received respectively within left andright parallel upper tracks (70, 72) attached to under side (74) and toeach side of a selected breast aperture (76) formed in patient supportplatform (78) of breast coil (18). Base (80) of breast coil (18) isconnected by centerline pillars (82) that are attached to patientsupport platform (78) between breast apertures (76). Also, a pair ofouter vertical support pillars (84, 86) on each side spaced about arespective breast aperture (76) respectively define lateral recess (88)within which localization fixture (16) resides.

It should be appreciated that the patient's breasts hang pendulouslyrespectively into breast apertures (76) within lateral recesses (88) inthe present example. For convenience, herein a convention is used forlocating a suspicious lesion by Cartesian coordinates within breasttissue referenced to localization fixture (16) and to thereafterselectively position an instrument, such as needle (90) of probe (91)that is engaged to holster portion (32) to form biopsy device (14). Ofcourse, any other type of coordinate system or targeting techniques maybe used. To enhance hands-off use of biopsy system (10), especially forrepeated re-imaging within the narrow confines of a closed bore MRImachine, biopsy system (10) may also guide obturator (92) encompassed bycannula (94). Depth of insertion is controlled by depth stop device (95)longitudinally positioned on either needle (90) or cannula (94).Alternatively, depth of insertion may be controlled in any othersuitable fashion.

This guidance is specifically provided by a lateral fence in the presentexample, depicted as grid plate (96), which is received within laterallyadjustable outer three-sided plate bracket (98) attached below left andright parallel upper guides (64, 66). Similarly, a medial fence withrespect to a medial plane of the chest of the patient, depicted asmedial plate (100), is received within inner three-sided plate bracket(102) attached below left and right parallel upper guides (64, 66) closeto centerline pillars (82) when installed in breast coil (18). Tofurther refine the insertion point of the instrument (e.g., needle (90)of probe (91), obturator/cannula (92, 94), etc.), guide cube (104) maybe inserted into grid plate (96).

In the present example, the selected breast is compressed along an inner(medial) side by medial plate (100) and on an outer (lateral) side ofthe breast by grid plate (96), the latter defining an X-Y plane. TheX-axis is vertical (sagittal) with respect to a standing patient andcorresponds to a left-to-right axis as viewed by a clinician facing theexternally exposed portion of localization fixture (16). Perpendicularto this X-Y plane extending toward the medial side of the breast is theZ-axis, which typically corresponds to the orientation and depth ofinsertion of needle (90) or obturator/cannula (92, 94) of biopsy device(14). For clarity, the term Z-axis may be used interchangeably with“axis of penetration”, although the latter may or may not be orthogonalto the spatial coordinates used to locate an insertion point on thepatient. Versions of localization fixture (16) described herein allow anon-orthogonal axis of penetration to the X-Y axis to a lesion at aconvenient or clinically beneficial angle.

It should be understood that the above-described localization assembly(15) is merely one example. Any other suitable type of localizationassembly (15) may be used, including but not limited to localizationassemblies (15) that use a breast coil (18) and/or localization fixture(16) different from those described above. Other suitable components,features, configurations, functionalities, operability, etc. for alocalization assembly (15) will be apparent to those of ordinary skillin the art in view of the teachings herein.

III. Biopsy Device

As shown in FIG. 1, one version of biopsy device (14) may compriseholster portion (32) and probe (91). Exemplary holster portion (32) wasdiscussed previously in the above section addressing control module(12). The following paragraphs will discuss probe (91) and associatedcomponents and devices in further detail.

In the present example, cannula (94) and obturator (92) are associatedwith probe (91). In particular, and as shown in FIGS. 4, 5, and 7,obturator (92) is slid into cannula (94) and the combination is guidedthrough guide cube (104) to the biopsy site within the breast tissue.Obturator (92) is then withdrawn from cannula (94), then needle (90) ofprobe (91) is inserted in cannula (94), and then biopsy device (14) isoperated to acquire one or more tissue samples from the breast vianeedle (90).

Cannula (94) of the present example is proximally attached tocylindrical hub (198) and cannula (94) includes lumen (196) and lateralaperture (200) proximate to open distal end (202). Cylindrical hub (198)has exteriorly presented thumbwheel (204) for rotating lateral aperture(200). Cylindrical hub (198) has interior recess (206) that encompassesduckbill seal (208), wiper seal (210) and seal retainer (212) to providea fluid seal when lumen (196) is empty and for sealing to insertedobturator (92). Longitudinally spaced measurement indicia (213) along anouter surface of cannula (94) visually, and perhaps physically, providea means to locate depth stop device (95) of FIG. 1.

Obturator (92) of the present example incorporates a number ofcomponents with corresponding features. Hollow shaft (214) includesfluid lumen (216) that communicates between imageable side notch (218)and proximal port (220). Hollow shaft (214) is longitudinally sized toextend, when fully engaged with cannula (94), piercing tip (222) out ofdistal end (202) of cannula (94). Obturator thumbwheel cap (224)encompasses proximal port (220) and includes locking feature (226),which includes visible angle indicator (228), that engages cannulathumbwheel (204) to ensure that imageable side notch (218) is registeredto lateral aperture (200) in cannula (94). Obturator seal cap (230) maybe engaged proximally into obturator thumbwheel cap (224) to close fluidlumen (216). Obturator seal cap (230) of the present example includeslocking or locating feature (232) that includes visible angle indicator(233) that corresponds with visible angle indicator (228) on obturatorthumbwheel cap (224), which may be fashioned from either a rigid, soft,or elastomeric material. In FIG. 7, guide cube (104) has guidedobturator (92) and cannula (94) through grid plate (96).

While obturator (92) of the present example is hollow, it should beunderstood that obturator (92) may alternatively have a substantiallysolid interior, such that obturator (92) does not define an interiorlumen. In addition, obturator (92) may lack side notch (218) in someversions. Other suitable components, features, configurations,functionalities, operability, etc. for an obturator (92) will beapparent to those of ordinary skill in the art in view of the teachingsherein. Likewise, cannula (94) may be varied in a number of ways. Forinstance, in some other versions, cannula (94) has a closed distal end(202). As another merely illustrative example, cannula (94) may have aclosed piercing tip (222) instead of obturator (92) having piercing tip(222). In some such versions, obturator (92) may simply have a bluntdistal end; or the distal end of obturator (92) may have any othersuitable structures, features, or configurations. Other suitablecomponents, features, configurations, functionalities, operability, etc.for a cannula (94) will be apparent to those of ordinary skill in theart in view of the teachings herein. Furthermore, in some versions, oneor both of obturator (92) or cannula (94) may be omitted altogether. Forinstance, needle (90) of probe (91) may be directly inserted into aguide cube (104), without being inserted into guide cube (104) viacannula (94).

Another component that may be used with probe (91) (or needle (90)) isdepth stop (95). Depth stop may be of any suitable configuration that isoperable to prevent cannula (94) and obturator (92) (or needle (90))from being inserted further than desired. For instance, depth stop (95)may be positioned on the exterior of cannula (94) (or needle (90)), andmay be configured to restrict the extent to which cannula (94) isinserted into a guide cube. It should be understood that suchrestriction by depth stop (95) may further provide a limit on the depthto which the combination of cannula (94) and obturator (92) (or needle(90)) may be inserted into the patient's breast. Furthermore, it shouldbe understood that such restriction may establish the depth within thepatient's breast at which biopsy device (14) acquires one or more tissuesamples after obturator (92) has been withdrawn from cannula (94) andneedle (90) has been inserted in cannula (94). Exemplary depth stops(95) that may be used with biopsy system (10) are described in U.S. Pub.No. 2007/0255168, entitled “Grid and Rotatable Cube Guide LocalizationFixture for Biopsy Device,” published Nov. 1, 2007, and incorporated byreference herein as mentioned previously.

In the present example, and as noted above, biopsy device (14) includesa needle (90) that may be inserted into cannula (94) after thecombination of cannula (94) and obturator (92) has been inserted to adesired location within a patient's breast and after obturator (92) hasbeen removed from cannula (94). Needle (90) of the present examplecomprises a lateral aperture (not shown) that is configured tosubstantially align with lateral aperture (200) of cannula (94) whenneedle (90) is inserted into lumen (196) of cannula (94). Probe (91) ofthe present example further comprises a rotating and translating cutter(not shown), which is driven by components in holster (32), and which isoperable to sever tissue protruding through lateral aperture (200) ofcannula (94) and the lateral aperture of needle (90). Severed tissuesamples may be retrieved from biopsy device (14) in any suitablefashion.

By way of example only, biopsy device (14) may be configured andoperable in accordance with the teachings of U.S. Pub. No. 2008/0228103,entitled “Vacuum Timing Algorithm For Biopsy Device,” published Sep. 18,2008, the disclosure of which is incorporated by reference herein. Asanother merely illustrative example, biopsy device (14) may beconfigured and operable in accordance with the teachings of U.S. patentapplication Ser. No. 12/337,874, entitled “Mechanical Tissue SampleHolder Indexing Device,” filed Dec. 18, 2008, the disclosure of which isincorporated by reference herein. As another merely illustrativeexample, biopsy device (14) may be configured and operable in accordancewith the teachings of U.S. patent application Ser. No. 12/337,674,entitled “Biopsy Device with Sliding Cutter Cover,” filed Dec. 18, 2008,the disclosure of which is incorporated by reference herein. By way ofexample only, cannula (94) may be replaced with any of the detachableneedles described in U.S. patent application Ser. No. 12/337,674,entitled “Biopsy Device with Sliding Cutter Cover.” As another merelyillustrative example, biopsy device (14) may be configured and operablein accordance with the teachings of U.S. patent application Ser. No.12/337,911, entitled “Biopsy Device with Discrete Tissue Chambers,”filed Dec. 18, 2008, the disclosure of which is incorporated byreference herein. As another merely illustrative example, biopsy device(14) may be configured and operable in accordance with the teachings ofU.S. patent application Ser. No. 12/337,942, entitled “Biopsy Devicewith Central Thumbwheel,” filed Dec. 18, 2008, the disclosure of whichis incorporated by reference herein. Alternatively, biopsy device (14)may have any other suitable components, features, configurations,functionalities, operability, etc. Other suitable variations of biopsydevice (14) and associated components will be apparent to those ofordinary skill in the art in view of the teachings herein

IV. Guide Cubes

Guide cubes described below are generally adapted for use with alocalization assembly (15) as described above. Numerous features ofmerely exemplary guide cubes will be discussed in the paragraphs thatfollow.

A. Guide Cubes Generally

In some versions, guide cubes may comprise a body defined by one or moreedges and faces. The body may include one or more guide holes or othertypes of passages that extend between faces of the guide cube and thatmay be used to guide an instrument such as a biopsy device (14) or aportion of a biopsy device (14) (e.g., needle (90) of biopsy device(14), a combination of cannula (94) and obturator (92), etc.). Guidecubes may be rotatable about one, two, or three axes to position the oneor more guide holes or passages of the guide cube into a desiredposition.

Referring now to FIG. 8, guide cube (104), includes central guide hole(106), corner guide hole (108), and off-center guide hole (110) thatpass orthogonally to one another between respective opposite pairs offaces (112, 114, 116). By selectively rotating guide cube (104) in twoaxes, one pair of faces (112, 114, 116) may be proximally aligned to anunturned position and then the selected proximal face (112, 114, 116)optionally rotated a quarter turn, half turn, or three-quarter turn.Thereby, one of nine guide positions (118, 120 a-120 d, 122 a-122 d) maybe proximally exposed as depicted in FIG. 9. More specifically, centralguide hole (106) may provide for guide position (118), corner guide hole(108) may provide for guide positions (120 a-120 d), and off-centerguide hole (110) may provide for guide positions (122 a-122 d).

In FIG. 6, two-axis rotatable guide cube (104) is sized for insertionfrom a proximal side into one of a plurality of square recesses (130) ingrid plate (96), which are formed by intersecting vertical bars (132)and horizontal bars (134). Guide cube (104) is prevented from passingthrough grid plate (96) by backing substrate (136) attached to a frontface of grid plate (96). Backing substrate (136) includes respectivesquare opening (138) centered within each square recess (130), forminglip (140) sufficient to capture the front face of guide cube (104), butnot so large as to obstruct guide holes (104, 106, 108). The depth ofsquare recesses (130) is less than guide cube (104), thereby exposing aproximal portion (142) of guide cube (104) for seizing and extractionfrom grid plate (96). It will be appreciated by those of ordinary skillin the art based on the teachings herein that backing substrate (136) ofgrid plate (96) may be omitted altogether in some versions. In some suchversions without backing substrate (136) other features of a guide cube,as will be discussed in more detail below, may be used to securely andremovably fit a guide cube within a grid plate. However, such otherfeatures may also be used in combination with a grid plate havingbacking substrate (136), such as grid plate (96), instead of partiallyor wholly omitting backing substrate (136).

B. Self-Grounding Guide Cubes

In FIG. 10, guide cube (104 a) has self-grounding by means of addedrectangular prism (240) which has a shared edge with cubic portion (242)of guide cube (104 a). When viewed orthogonally to the shared cube edge,larger square face (244) of cubic portion (242) overlaps with smallersquare face (246) of rectangular prism (240). As shown in FIG. 11,rectangular prism (240) allows proximal exposure of one of two adjacentfaces (250, 252) of guide cube (104 a) and then turning each to one offour quarter-turn rotational positions. In the illustrative version,first face (250) has central guide hole (106 a) and second face (252)has corner guide hole (108 a), and off-center guide hole (110 a). Radialrecess (254) is formed in rectangular prism (240) to allow grounding ofdepth stop device (95) against face (252) when off-center guide hole(110 a) is used.

In FIG. 12, guide cube (104 b) has self-grounding by means of addedrectangular prism (260) that protrudes from two faces (262, 264) ofguide cube (104 b). Rectangular prism (260) allows proximal exposure ofone of two adjacent faces (262, 264) of guide cube (104 b) and thenturning each to one of four quarter-turn rotational positions. In theillustrative version, first face (262) has central guide hole (106 b)and second face (264) has corner guide hole (108 b) and off-center guidehole (110 b). First radial recess (266) is formed in rectangular prism(260) to allow grounding of depth stop device (95) against face (264)when off-center guide hole (110 b) is used. Second radial recess (268)is formed in rectangular prism (260) to allow grounding of depth stopdevice (95) against face (262) when central guide hole (106 b) is used.As discussed in greater detail below, guide cube (104 b) may have opentop (261) and/or an open bottom (not shown) defined by the faces ofguide cube (104 b) as depicted in the illustrated version.

In FIGS. 13-15, guide cube (104 c) has proximal enlarged hat portion(270) about proximal face (271) that grounds against selected squarerecess (130), such as in grid plate (96), and allows rotation about oneaxis to one of four quarter-turn positions. Four angled guide holes (272a, 272 b, 272 c, 272 d) allow accessing not only an increased number ofinsertion points within selected square recess (130) but also a desiredangle of penetration rather than being constrained to a perpendicularinsertion. It will be appreciated based on the teachings herein thatwhile angled guide holes may be used in some versions, orthogonal guideholes may be used instead of or in addition to angled guide holes inother versions.

C. Elastomeric Edges

In FIGS. 16 and 17, guide cube (304) includes body (306) defined by fourfaces (308, 310, 312, 314). Faces (308, 310, 312, 314) include two setsof opposing faces, as shown in the illustrated version where face (308)and face (310) are opposing and likewise face (312) and face (314) areopposing. Guide cube (304) has guide holes (316, 318, 320) passingthrough guide cube (304). Guide holes (316, 318, 320) have correspondingopenings in a set of opposing faces thereby providing access via apassageway from one side of guide cube (304) to the other side. Itshould be appreciated that guide holes may be configured to share acommon opening in a face in some versions. As shown in the illustratedversion, faces (308, 310) include central guide hole (316), while faces(312, 314) include corner guide hole (318) and off-center guide hole(320). However, it should be understood that faces (308, 310, 312, 314)may each have any suitable number of guide holes in any suitablepositioning or arrangements, and that any suitable number of passagesmay be provided through guide cube (304).

Each face (308, 310, 312, 314) of guide cube (304) may be defined byedges. In such a configuration, it will be appreciated that some faces(308, 310, 312, 314) may share one or more common edges. For instance,face (308) may be defined by edges (322 a-322 d). Face (312) may bedefined by edges (326 a-326 c, 322 d). Face (310) may be defined byedges (324 a-324 c, 326 c). Face (314) may be defined by edges (328 a,328 b, 322 c, 324 c). It should be further appreciated that faces (308,310, 312, 314) may be configured such that each does not share commonedges, but rather the edges of adjacent faces abut one another formingthe edges (322 a-322 d, 324 a-324 c, 326 a-326 c, 328 a-328 b) of guidecube (304). For instance, faces (308, 310, 312, 314) may be initiallyformed separately, such as by being formed as separate plates, with eachplate having its own four edges, and with the separate plates beingjoined together to form guide cube (304), etc.).

As shown in FIG. 16, at least a portion of edges (322 a-322 d, 324 a-324c, 326 a-326 c, 328 a-328 b) of guide cube (304) may be comprised of orfitted with elastomeric material. In FIG. 16, edges (322 a, 324 a, 326a, 328 a, 322 b, 324 b, 326 b, and 328 b) are comprised of elastomericmaterial. This provides guide cube (304) with the opposing edges of fourfaces (308, 310, 312, 314) having an elastomeric edge. Based on theteachings herein, it will be appreciated that other guide cube versionsmay arrange the elastomeric edges in any suitable configuration. Forinstance in other versions all edges of a guide cube may haveelastomeric edges. Any arrangement of elastomeric edges that aids inimproved fit of a guide cube with a grid plate may be suitable.

Guide cube (304) may further be rotatable in two axes withself-grounding by means of rectangular prism (330) that protrudes fromtwo faces (308, 312) of guide cube (304). Rectangular prism (330) allowsproximal exposure of one of two adjacent faces (308, 312) of guide cube(304) and then turning each to one of four quarter-turn rotationalpositions. In the illustrative version, first radial recess (332) isformed in rectangular prism (330) to allow grounding of depth stopdevice (95) against face (312) when off-center guide hole (320) is used.Second radial recess (334) is formed in rectangular prism (330) to allowgrounding of depth stop device (95) against face (308) when centralguide hole (316) is used.

Guide cube (304) may have open top (336) and/or an open bottom (notshown) defined by faces (308, 310, 312, 314) of guide cube (304) asdepicted in the illustrated version. Open top (336) and open bottom (notshown) may provide void volume within guide cube (304), and depending onthe rigidity of body (306), body portion (306) may flex to some degreethereby permitting better fit within a grid plate or more compatible fitwithin various grid plates. Alternatively, guide cube (304) may have aclosed top and/or bottom. Similarly, aside from the passageways providedbetween guide holes (316, 318, 320), the interior of guide cube (304)may be substantially hollow or substantially solid, as desired.

Based on the teachings herein, those of ordinary skill in the art willappreciate that several elastomeric materials may be suitable for usewith guide cube (304). By way of example only, suitable elastomericmaterials may include thermosetting plastics that may requirevulcanization, thermoplastic elastomers (e.g. Santoprene™ among others),natural rubber, synthetic rubbers (e.g. ethylene propylene dieneM-class—EPDM—among others), and other polymers having suitable elasticproperties.

Creating a guide cube having elastomeric edges may be accomplished in avariety of ways. For example, in creating a guide cube such as guidecube (304) that has elastomeric edges (322 a, 324 a, 326 a, 328 a, 322b, 324 b, 326 b, 328 b), in some versions a multi-shot molding processmay be used where body (306) of guide cube (304) may be molded from afirst material, e.g. a non-elastomeric material, and the elastomericedges may be molded from a second material, e.g. an elastic material asdescribed above or otherwise. In some other versions, elastomeric edges(322 a, 324 a, 326 a, 328 a, 322 b, 324 b, 326 b, 328 b) may be moldedor extruded separate from body (306) and then coupled with body (306) bymechanical fastening, chemical adhesive, or other suitable bonding orcoupling techniques.

Based on the teachings herein, those of ordinary skill in the art willappreciate that the configuration of the elastomeric edges, the type ofelastomeric material used for the edges, the application process used toapply the elastomeric material to the edges, and other factors mayinfluence whether or not a specific elastomeric edge design and materialare suitable. Those of ordinary skill in the art, based on the teachingsherein, will further appreciate that suitable designs for a guide cubehaving at least one elastomeric edge may create a secure interferencebetween a grid plate and guide cube without significantly increasing theforce required to insert or remove the guide cube from the grid plate.Accordingly, guide cube (304) of the present example may fit in varioustypes of grid plates having grid openings or recesses of various sizesor configurations. It should also be understood that, in some settings,the presence of elastomeric material on edges (322 a, 324 a, 326 a, 328a, 322 b, 324 b, 326 b, 328 b) may provide sufficient friction with agrid plate to reduce the likelihood that guide cube (304) willundesirably fall out of the grid plate. In addition, other suitablefeatures, configurations, components, functionalities, operability, andvariations of guide cube (304) will be apparent to those of ordinaryskill in the art in view of the teachings herein.

D. Elastomeric Body

FIGS. 18-21 depict other versions of guide cubes that comprise anelastomeric body that may compress to fit with multiple grid plateshaving openings that may vary in shape and/or size from grid plate togrid plate, or even within a single grid plate. Those of ordinary skillin the art will appreciate, based on the teachings herein, that theelastomeric nature of the body in these examples may greatly increasethe compatibility of the guide cubes for use with various grid plates.In addition to, or separately from the elastomeric body compressing tofit with multiple grid plates, FIGS. 18-21 also depict versions of guidecubes having expanding access ports. The expanding access ports may bedefined by or surrounded by an elastomeric body or a portion of anelastomeric body that allows expansion of the access ports when aportion of a biopsy device is inserted into an access port. While theconcept of an elastomeric body is described in greater detail below withreference to examples depicted in FIGS. 18-21, it should be understandthat the concept may alternatively be applied to any guide cubedescribed herein and to variations of such guide cubes. Accordingly, theconcept of an elastomeric body is not necessarily limited to theexamples depicted in FIGS. 18-21 and described below.

Referring now to FIG. 18, guide cube (400) has elastomeric body (408)having nine access slits (410) for receiving probe (91) and/or othercomponents of biopsy device (14). Of course, any other suitable numberof access slits (410) may be provided, including more than nine or lessthan nine. It should also be understood that slits (410) may be ofvarious lengths and/or widths, etc. The nature of elastomeric body (408)allows body (408) to compress when fitted within a smaller opening in agrid plate. When in a compressed state and inserted into an opening in agrid plate, the elastomeric body (408) provides a force against innerwall portions of the grid plate that define the grid plate opening, suchthat the guide cube (400) is securely held in position. As discussedpreviously, a portion of guide cube (400) may protrude from the proximalside of the grid plate such that guide cube (400) remains accessible tothe user. To remove guide cube (400), the user may grasp the protrudingportion of guide cube (400), provide further compressive force to reducethe size of guide cube (400), and withdrawal guide cube (400) from thegrid plate opening.

Guide cube (400) further may comprise access slits (410) that extendfrom first face (414) through guide cube (400) to opposing face (notshown), to provide a passageway between opposing faces. In theillustrated version, biopsy device (14) may be used with any of selectedaccess slits (410) with or without the need to rotate guide cube (400).In use, when the combination of cannula (94) and obturator (92) (orneedle (90)) is inserted into a selected access slit (410), the natureof elastomeric body (408) surrounding access slit (410) is such thatelastomeric body (408) may compresses to accommodate the volume of theintroduced combination of cannula (94) and obturator (92) (or needle(90)). It should be understood that entire length of cannula (94) (orneedle (90)) need not be inserted into a guide hole or access slits(410) and that in some versions only a portion of the length of cannula(94) (or needle (90)) may be inserted into the guide holes or accessslits (410). In some versions, nearby access slits (410) or guide holesthat do not receive the combination of cannula (94) and obturator (92)(or needle (90)) may compress upon the insertion of the combination ofcannula (94) and obturator (92) (or needle (90)) into the selectedaccess slit (410). In some versions, where guide cube (400) is insertedinto a grid plate opening, the insertion of the combination of cannula(94) and obturator (92) (or needle (90)) into access slit (410) causeselastomeric body (408) to exert further force against the walls of thegrid plate that define the grid plate opening. It will be appreciatedbased on the teachings herein that elastomeric body (408) and accessslits (410) may work together to provide a sufficient outward force fromguide cube (400) to the walls defining the grid plate opening such thatguide cube (400) fits within the grid plate opening securely both duringinsertion of the combination of cannula (94) and obturator (92) (orneedle (90)) through access slit (410) and during withdrawal of cannula(94) (or needle (90)) through access slit (410).

Referring now to FIG. 19, guide cube (402) has elastomeric body (408)having nine access star-shaped openings (412) for receiving probe (91)and/or other components of biopsy device (14). Of course, any othersuitable number of openings (412) may be provided, including more thannine or less than nine. Similarly, openings (412) need not bestar-shaped, and can have any other suitable shape. For instance,openings (412) may include any type of undersized access openings withany number of slits around (e.g., extending radially outwardly relativeto) the perimeter of each opening. “Undersized” in some settings maymean that the diameter of a relaxed opening (412) (e.g., one without acannula (94) (or needle (90)) inserted in it) is less than the diameterof a cannula (94) (or needle (90)). The nature of elastomeric body (408)in the present example allows body (408) to compress when fitted withina smaller opening in a grid plate. When in a compressed state andinserted into an opening in a grid plate, the elastomeric body (408)provides a force against inner wall portions of the grid plate thatdefine the grid plate opening, such that the guide cube (402) issecurely held in position. As discussed previously, a portion of guidecube (402) may protrude from the proximal side of the grid plate suchthat guide cube (402) remains accessible to the user. To remove guidecube (402), the user may grasp the protruding portion of guide cube(402), provide further compressive force to reduce the size of guidecube (402), and withdrawal guide cube (402) from the grid plate opening.

Guide cube (402) further may comprise access star-shaped openings (412)that extend from first face (420) through guide cube (402) to opposingface (not shown), to provide a passageway between opposing faces. In theillustrated version, biopsy device (14) may be used with any of selectedaccess openings (412) with or without the need to rotate guide cube(402). In use, when the combination of cannula (94) and obturator (92)(or needle (90)) is inserted into a selected access opening (412), thenature of elastomeric body (408) surrounding access opening (412) issuch that elastomeric body (408) may compresses to accommodate thevolume of the introduced combination of cannula (94) and obturator (92)(or needle (90)). It should be understood that entire length of canula(94) (or needle (90)) need not be inserted into a guide hole or accessopening (412) and that in some versions only a portion of the length ofcannula (94) (or needle (90)) may be inserted into the guide holes oraccess openings (412). In some versions nearby access openings (412) orguide holes that do not receive the combination of cannula (94) andobturator (92) (or needle (90)) may compress upon the insertion of thecombination of cannula (94) and obturator (92) (or needle (90)) into theselected access opening (412). In some versions, where guide cube (402)is inserted into a grid plate opening, the insertion of the combinationof cannula (94) and obturator (92) (or needle (90)) into access opening(412) causes elastomeric body (408) to exert further force against thewalls of the grid plate that define the grid plate opening. It will beappreciated based on the teachings herein that elastomeric body (408)and access openings (412) may work together to provide a sufficientoutward force from guide cube (402) to the walls defining the grid plateopening such that guide cube (402) fits within the grid plate openingsecurely both during insertion of the combination of cannula (94) andobturator (92) (or needle (90)) through access opening (412) and duringwithdrawal of cannula (94) (or needle (90)) through access opening(412).

It should be understood that guide cubes (400, 402) shown in FIGS. 18-19may be rotatable about one, two, or three axes to provide a desiredorientation of passageways defined by slits (410) or openings (412)relative to grid plate (96). For instance, in the versions depicted inFIGS. 18-19, guide cubes (400, 402) may be rotatable about an axisextending through face (414, 420), among other axes. While slits (410)and openings (412) are shown in FIGS. 18-19 as being substantiallyequidistantly spaced and distributed across face (414, 420), any othersuitable arrangements or positioning may be provided. In addition, whileslits (410) and openings (412) only provide passageways from one face(414, 420) to an opposing face (not shown), it should be understood thatslits (410) or openings (412) may additionally be provided in otherfaces of guide cubes (400, 402). Still other suitable variations ofguide cubes (400, 402) will be apparent to those of ordinary skill inthe art in view of the teachings herein.

Referring now to FIGS. 20 and 21, guide cubes (404, 406) may berotatable (e.g., about one, two, or three axes) and have guide holes(414, 415) that extend between opposing faces of guide cube (404, 406)to provide passageways between opposing faces of guide cube (404, 406).As shown, some versions may include guide cubes (404, 406) having threeguide holes (414, 415), still other versions may include either more orfewer guide holes (414, 415). Guide holes (414, 415) may define arelaxed diameter that is less than the diameter of cannula (94) orneedle (90), but may further include a feature that allows for expansionof guide holes (414, 415) when the combination of cannula (94) andobturator (92) (or needle (90)) is inserted. In some cases, the presenceof an expanding feature may reduce skiving when inserting thecombination of cannula (94) and obturator (92) (or needle (90)). Asshown in FIG. 20, guide holes (414) include slits (438) that expand whenthe combination of cannula (94) and obturator (92) (or needle (90)) isinserted. As shown in FIG. 21, guides holes (415) may have a star-shapewhere extending flares (440) may expand when the combination of cannula(94) and obturator (92) (or needle (90)) is inserted.

As noted above with respect to guide cubes (400, 402), guide cubes (404,406) may be rotatable about one, two, or three axes to provide a desiredorientation of passageways defined by guide holes (414, 415) relative togrid plate (96). For instance, in the versions depicted in FIGS. 20-21,guide cubes (404, 406) may be rotatable about an axis extending throughface (426, 432), among other axes. Furthermore, guide holes (414, 415)may have any suitable arrangement or positioning that is different fromthe arrangements shown in FIGS. 20-21. In addition, guide holes (414,415) only provide passageways from one face (426, 432) to an opposingface (not shown), it should be understood that guide holes (414, 415)may additionally be provided in other faces of guide cubes (404, 406).Still other suitable variations of guide cubes (404, 406) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

In some versions of guide cubes (400, 402, 404, 406) having anelastomeric body (408), multiple durometers may be used when creatingbody (408). In some such versions, the multiple durometer design mayprevent rotation, angulation, or other movement of the inserted portionof biopsy probe (14) when in use. For example, the inner portion ofslits (410) or star-shaped openings (412) may be harder than otherportions of body (408) to prevent angulation or movement of biopsydevice (14), while the outer grid-contacting portions of body (408) maybe softer to allow for greater compatibility of fit with multiple gridplate versions. Similarly, guide holes (414, 415) of guide cubes (404,406) may be harder than other portions of body (408) to preventangulation or movement of biopsy device (14), while the outergrid-contacting portions of the body (408) may be softer to allow forgreater compatibility of fit with multiple grid plate versions. In someversions guide cubes (400, 402, 404, 406) may even have guide holes(414, 415) constructed from a rigid material, e.g. a polycarbonate, toprevent angulation or movement of biopsy device (14). The rigid materialof guide holes (414, 415) may then be surrounded by elastomeric body(408) to allow for greater compatibility of fit with multiple grid plateversions or for other purposes.

Still in some other versions guide cubes (400, 402, 404, 406) may haveno predefined guide holes or passageways for receiving probe (91) orother components of biopsy device (14). In such versions guide cubes(400, 402, 404, 406) may be penetrable such that the user may define orcreate a passageway through guide cubes (400, 402, 404, 406). In somesuch versions the user may define or create a passageway by inserting acombination of cannula (94) and obturator (92) (or needle (90)) throughbody (408) of guide cube (400, 402, 404, 406). It will be appreciatedbased on the teachings herein that the construction of guide cubes (400,402, 404, 406) in versions where the user defines a passageway may besuch that body (408) of guide cube (400, 402, 404, 406) is sufficientlyweak to be penetrable by combinations of cannula (94) and obturator (92)(or needle (90)), yet at the same time body (408) of the guide cube(400, 402, 404, 406) is sufficiently strong to prevent biopsy device(14) from unwanted angulation or other undesired movement afterinsertion. In some user-defined passageway versions of guide cubes,guide cube (400, 402, 404, 406) may be constructed from an elastomericmaterial, rigid material, or combinations of these or other suitablematerials.

Based on the teachings herein, those of ordinary skill in the art willappreciate that several elastomeric materials may be suitable for usewith guide cubes (400, 402, 404, 406). By way of example only, suitableelastomeric materials may include thermosetting plastics that mayrequire vulcanization, thermoplastic elastomers (e.g. Santoprene™ amongothers), natural rubber, synthetic rubbers (e.g. ethylene propylenediene M-class—EPDM—among others), and other polymers having suitableelastic properties.

In some versions, the elastomeric used for body (408) may be imbedded orcoated with a lubricant. The lubricant may make it easier to insert andremove the combination of cannula (94) and obturator (92) (or needle(90))) from guide cubes (400, 402, 404, 406) and further reduce thepotential for skiving.

Creating guide cubes (400, 402, 404, 406) having elastomeric body (408)may be accomplished in a variety of ways. For example, in some versionsa multi-shot molding process may be used where an inner portion of body(408) of guide cubes (400, 402, 404, 406) may be molded from a firstmaterial having a first durometer, and an outer portion of body (408)may be molded from a second material having a second durometer. In someother versions, elastomeric body (408) may be manufactured as separateparts later coupled together to form body (408). In such a version, theparts of body (408) may be coupled together by mechanical fastening,chemical adhesive, or other suitable bonding or coupling techniques.Still it should be appreciated that body (408) may be molded or extrudedas a single unitary piece having a uniform composition of elastomericmaterial.

Based on the teachings herein, those of ordinary skill in the art willappreciate that the configuration of elastomeric body (408), the typesof elastomeric materials used for body (408), the application processesused to create elastomeric body (408), and other factors may influencewhether or not a specific elastomeric body design is suitable. Those ofordinary skill in the art, based on the teachings herein, will furtherappreciate that suitable designs for guide cubes having an elastomericbody may create a secure interference between a grid plate and the guidecube without significantly increasing the force required to insert orremove the guide cube from the grid plate. Accordingly, guide cubes(400, 402, 404, 406) of the present example may fit in various types ofgrid plates having grid openings or recesses of various sizes orconfigurations. It should also be understood that, in some settings, theelastomeric properties of body (408) may provide sufficient frictionwith a grid plate to reduce the likelihood that guide cube (400, 402,404, 406) will undesirably fall out of the grid plate. Furthermore, itwill be appreciated based on the teachings herein that suitable designsfor a guide cube having an elastomeric body may create a secureinterface between a probe or other components of a biopsy device and acorresponding guide hole or access port of the body.

In some versions of guide cubes (400, 402, 404, 406) having elastomericbody (408), additional self-grounding features as discussed above may beincluded. For instance rectangular prism self-grounding member (240,260, 330) may be adapted for use with guide cubes (400, 402, 404, 406).In other versions, guide cubes (400, 402, 404, 406) may incorporateenlarged hat portion (270) as a self-grounding feature. It should beappreciated that the self-grounding features may or may not be comprisedof elastomeric material. Furthermore, it should be appreciated that theself-grounding features may be entirely omitted from guide cubes (400,402, 404, 406) in lieu of other grounding features incorporated with agrid plate or other components. Still, it should be appreciated thatelastomeric body (408) itself may serve as the self-grounding featurefor guide cubes (400, 402, 404, 406). In such a version, the outwardforce exerted by elastomeric body (408) against the inner walls of thegrid plate may provide the grounding feature holding guide cubes (400,402, 404, 406) securely in place. Still other suitable features,configurations, components, functionalities, operability, and variationsof guide cube (400, 402, 404, 406) will be apparent to those of ordinaryskill in the art in view of the teachings herein.

E. Elastomeric Body with Malleable Members

FIGS. 22 and 23 depict another exemplary version of a guide cube (500).Some versions of guide cube (500) may facilitate the ability to angleprobe (91) and/or other components of biopsy device (14) and maintainthe desired angle. In the illustrated version, guide cube (500)comprises body (502) defined by pairs of opposing faces that includefaces (504, 506, 508) and other faces (not shown). Body (502) may beconstructed wholly or partially from an elastomeric material, asdiscussed above or otherwise.

Guide cube (500) may further include one or more guide holes (510) thatprovide passageways between pairs of opposing faces, e.g. face (504) andits opposing face (not shown), and face (506) and its opposing face (notshown). Referring to FIG. 22, guide holes (510) may initially bepositioned perpendicular to the associated pair of opposing faces.Adjacent and parallel to each guide hole (510) are wires (512) in thepresent example. Wires (512) may be overmolded or substantiallysurrounded by the elastomeric material comprising body (502) of guidecube (500). Alternatively, wires (512) may be inserted into body (502)or otherwise provided in body (502). Wires (512) may be made from anon-magnetic material such that no MRI artifact, or only a minimal MRIartifact, will occur during an associated imaging procedure. Somesuitable materials for wires (512) may include, but are not limited to,cobalt alloys such as cobalt L605, aluminum alloys such as aluminum6061, stainless steel alloys such as 316L stainless steel, titaniumalloys such as titanium 6, nickel-cobalt alloys such as MP35N, and othersuitable alloys. Alternatively, wires (512) may be formed of any othersuitable materials or combinations of materials.

In use, the combination of cannula (94) and obturator (92) (or needle(90))) may be inserted through one of guide holes (510). To the extentthat a combination of cannula (94) and obturator (92) is used, obturator(92) may then be removed from cannula (92), and needle (90) may then beinserted in cannula (94). Biopsy device (14) may then be angled to adesired position (e.g., providing a desired angular orientation ofneedle (90)). The action of angling biopsy device (14) may cause wires(512) to undergo a plastic deformation such that wires (512) aremalleable and hold their position once biopsy device (14) reaches adesired orientation. The elastomeric nature of body (502) of guide cube(500) allows body (502) to conform to the angled orientation of biopsydevice (14). Moreover, the construction of guide cube (500) may be suchthat wires (512), once in their bent position, withstand any biasingforces by body (502) that may attempt to return guide cube (500) to itsinitial state. In such versions, the angled orientation of insertedbiopsy device (14) may thus be maintained without the user or anotherperson or apparatus holding biopsy device (14) at the desired position.Of course, in settings where an obturator (92) and cannula (94) areused, a user may first obtain a desired angular orientation with eithercannula (94) or the combination of obturator (92) and cannula (94)before inserting needle (90) into cannula (94). It should also beunderstood that a user need not necessarily adjust the angle of cannula(94) or needle (90) in guide cube (500), as wires (512) may simplyreinforce a substantially horizontal orientation or other predefinedorientation.

Guide cube (500) may further include a self-grounding member, such asrectangular prism (514) shown in FIGS. 22 and 23. However, it should beappreciated based on the teachings herein that other suitable groundingfeatures may be used in addition to or instead of rectangular prism(514). Furthermore, it should be appreciated that guide cube (500) maybe rotatable to provide various guide hole (510) orientations eventhough guide cube (500) is configured to permit angling an insertedbiopsy device (14).

Based on the teachings herein, those of ordinary skill in the art willappreciate that several elastomeric materials may be suitable for usewith guide cube (500). By way of example only, suitable elastomericmaterials may include thermosetting plastics that may requirevulcanization, thermoplastic elastomers (e.g. Santoprene™ among others),natural rubber, synthetic rubbers (e.g. ethylene propylene dieneM-class—EPDM—among others), and other polymers having suitable elasticproperties.

Creating guide cube (500) with body (502) may be accomplished in avariety of ways. For example, in some versions molding process may beused where a first molding process creates guide holes (510). Then wires(512) may be placed around the guide holes (510), followed by a secondmolding process that over-molds wires (512) and guide holes (510) withmaterial that comprises body (502). In other versions, guide cube (500)may be molded or extruded as a single solid structure. Then bores may bemade in guide cube (500) by any suitable technique to create guide holes(510). Then wires (512) may pierce body (502) to be inserted into body(502) alongside guide holes (510). Those of ordinary skill in the artwill appreciate, based on the teachings herein, various other ways tocreate guide cube (500) of FIGS. 22 and 23, including but not limited tovarious other ways to position wires (512) in body (502).

As noted above with respect to guide cubes (400, 402, 404, 406), guidecube (500) may be rotatable about one, two, or three axes to provide adesired orientation of passageways defined by guide holes (510) relativeto grid plate (96). For instance, in the versions depicted in FIGS.22-23, guide cube (500) may be rotatable about axes extending throughfaces (504, 506), among other axes. Furthermore, guide holes (510) mayhave any suitable arrangement or positioning that is different from thearrangements shown in FIGS. 20-21. In addition, guide holes (510) onlyprovide passageways from one face (504, 506) to an opposing face (notshown), it should be understood that guide holes (510) may additionallybe provided in other faces of guide cube (500). Still other suitablevariations of guide cube (500) will be apparent to those of ordinaryskill in the art in view of the teachings herein.

Those of ordinary skill in the art, based on the teachings herein, willfurther appreciate that suitable versions of guide cube (500) havingelastomeric body (502) may improve fit and compatibility of guide cube(500) with various grid plates by creating a secure interference betweenthe grid plate and guide cube (500) without significantly increasing theforce required to insert or remove guide cube (500) from the grid plate.Accordingly, guide cube (500) of the present example may fit in varioustypes of grid plates having grid openings or recesses of various sizesor configurations. It should also be understood that, in some settings,the elastomeric properties of body (502) may provide sufficient frictionwith a grid plate to reduce the likelihood that guide cube (500) willundesirably fall out of the grid plate. Furthermore, it will beappreciated based on the teachings herein that suitable versions forguide cube (500) may create a secure interface between cannula (94),probe (91), or other components of biopsy device (14) and thecorresponding guide hole (510) of body (502), such that biopsy device(14) does not slip within guide hole (510) during use. In addition,other suitable features, configurations, components, functionalities,operability, and variations of guide cube (500) will be apparent tothose of ordinary skill in the art in view of the teachings herein. Itshould also be understood that any other guide cube described herein,and variations thereof, may include one or more wires (512) if desired,including but not limited to guide cubes (400, 402, 404, 406).

F. Tapered Guide Cubes

FIGS. 24-27 show other versions of guide cubes (600, 602) incorporatinga tapered feature to create guide cubes (600, 602) that conform to gridplates of various designs. Referring to FIGS. 24 and 25, guide cube(600) includes pairs of opposing faces that include faces (604, 605,606, 608, 609) and other faces (not shown). Guide cube (600) furtherincludes central guide hole (610), corner guide hole (612), andoff-center guide hole (614), which pass orthogonally between face (604)and face (605) to provide respective passageways through faces (604,605). As shown in the cross-section view in FIG. 25, face (604) and face(605) have unequal dimensions that create a taper from one side of guidecube (600) to the other side of guide cube (600). In use with a gridplate, the tapered sides (611) of guide cube (600) may permit guide cube(600) to securely interface with the opening in the grid plate byinserting guide cube (600) in the grid plate up to the point where thetapered sides (611) contact the interior walls of the opening in thegrid plate. In some settings, such an interface may be securely providedregardless of whether the interior walls of the opening in the gridplate are substantially horizontal and vertical along their length or atnon-horizontal and/or non-vertical angles along their length.

Based on the teachings herein, those of ordinary skill in the art willappreciate that additional grounding features may be incorporated orused with guide cube (600). For example, in some versions, guide cube(600) may be substantially rigid throughout. In some other versions,(e.g., where guide cube (600) is formed of a substantially rigidmaterial), guide cube (600) may be fitted with elastomeric edges aroundthe tapered sides (611), thereby providing some degree of compressionforce to further secure guide cube (600) in the grid plate. Guide holes(610, 612, 614) may also have an elastomeric material therein, inaddition to or in lieu of having elastomeric material at the edgesand/or faces (604, 605, 606, 608, 609) of guide cube (600). In stillother versions, guide cube (600) may have an elastomeric body capable ofcompression fitting within a grid plate. In some versions of taperedguide cube (600) incorporating an elastomeric body, a multi-step moldingprocess may be used to achieve guide holes (610, 612, 614) having ahigher durometer or more rigidity than the elastomeric body portionitself.

It should further be appreciated that guide cube (600) may comprisesmore than one pair of tapered sides (611). For example, opposing sidepair comprised of face (606) and opposing face (not shown) may also betapered, in addition to or in lieu of one or both sides (611) beingtapered. Alternatively, guide cube (600) may have just one tapered side(611). Still yet in other versions guide cube (600) may include morethan three pairs of opposing faces, thereby having a shape other than asix-sided cube. In such versions, one, some, or all of the sides may ormay not be tapered. Still other suitable features, configurations,components, functionalities, operability, and variations of guide cube(600) will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

Referring now to FIGS. 26 and 27, guide cube (602) includes set ofelastomeric bumps (616) that increase in height proximally as guide cube(602) is inserted in a grid plate. Elastomeric bumps (616) create ataper along face (618) of guide cube (602). The taper allows guide cube(602) to fit in multiple grid plates (e.g., different types of gridplates having differently sized openings). While FIGS. 26 and 27 showelastomeric bumps (616) on one face (618) of guide cube (602), in otherversions elastomeric bumps (616) may be located on any or all faces ofguide cube (602).

Guide cube (602) further comprises body (620) that may be constructedfrom a rigid material. However, based on the teachings herein, it willbe appreciated that body (620) may be constructed from an elastomericmaterial, partially constructed from an elastomeric material, orconstructed from any other suitable type of material (includingcombinations of materials having similar or different properties).Regardless of the construction of body (620), it will be appreciatedbased on the teachings herein that the guide holes (622) of the presentexample may be constructed from a material that prohibits or at leastrestricts unwanted angulation or movement of inserted probe (91) and/orother components of biopsy device (14). For instance, such restrictionor prohibition may be provided by the rigidity of body (620).Alternatively, such as in versions where body (620) is formed of anelastomeric material, such restriction or prohibition may be provided bya rigid sleeve inserted through guide holes (622), by one or more wires(512) positioned near guide holes (622), or in any other suitablefashion.

As shown in FIGS. 26 and 27, guide cube (602) may further includerectangular prism (624) self-grounding feature. The self-groundingfeature may be located along a corner of guide cube (602) and at aproximal end of guide cube (602) where elastomeric bumps (616) have thegreatest height. This arrangement may help ensure that elastomeric bumps(616) interface with the grid plate and compress accordingly untilrectangular prism (624) contacts the grid plate and blocks guide cube(602) from further insertion. It should also be understood thatelastomeric bumps (616) may provide some degree of compression force tofurther secure guide cube (600) in the grid plate. Furthermore, theelastomeric properties of bumps (616) may provide sufficient frictionwith a grid plate to reduce the likelihood that guide cube (602) willundesirably fall out of the grid plate. It should also be understoodthat any other guide cube described herein, and variations thereof, mayinclude one or more bumps (616) or similar features, if desired. Stillother suitable features, configurations, components, functionalities,operability, and variations of guide cube (602) will be apparent tothose of ordinary skill in the art in view of the teachings herein.

G. Hinged Guide Cubes

FIGS. 28-31 depict guide cube (700) having hinge members (702) thatpermit guide cube (700) to fit within grid plates having differentopening dimensions. As shown in FIG. 28, guide cube (700) includes hingemembers (702) along a pair of opposing faces comprising face (704) andface (705). Hinge members (702) originate from distal end (706) of guidecube (700) and extend at an angle proximally past proximal face (708) ofguide cube (700) defining a taper relative to face (704) and face (705)of guide cube (700). Each hinge member (702) may include outerelastomeric surface (710) that engages the interior walls of a gridplate when guide cube (700) is inserted into an opening in a grid plate.Each hinge member (702) may also include shoulder portion (712) thatextends past proximal face (708) as shown in FIGS. 28 and 31. Hingemembers (702) of the present example are coupled with the remainder ofguide cube (700) by living hinges that are resiliently biased to extendhinge members (702) outwardly as shown in FIG. 28. In addition or in thealternative, hinge members (702) themselves may be resiliently biased toextend outwardly. When guide cube (700) is inserted into a grid plate,shoulder portions (712) overlap grid lines (714) defining the opening ofthe grid plate and thus prevent over-insertion of guide cube (700) asshown in FIG. 30. Elastomeric surfaces (710), together with theresilient outward bias of hinge members (702), may provide sufficientfriction with a grid plate to reduce the likelihood that guide cube(700) will undesirably fall out of the grid plate.

In one example of operation, a user pinches hinge members (702) toward acenter of guide cube (700) that may be indicated by central guide hole(716). Then the user inserts guide cube (700) into a selected opening inthe grid plate, pushing guide cube (700) distally toward the patient andat the same time releasing hinge members (702). As guide cube (700) isbeing inserted, hinge members (702) resiliently push away from thecenter of guide cube (700) and contact the interior walls defining theopening in the grid plate. Elastomeric surfaces (710) of hinge members(702) may compress against the interior walls that define the opening inthe grid plate thereby securely fitting guide cube (700) within the gridplate. To release guide cube (700) from the grid plate, a user graspsshoulder portions (712) of hinge members (702), depressing hinge members(702) toward the center of guide cube (700). As shown in FIGS. 29 and30, proximal face (708) of guide cube (700) may include cut-out portions(718) that make room for proximal end protrusions (720) of hinge members(702) when hinge members (702) are pinched. With hinge members (702)pinched, elastomeric surfaces (710) may disengage the grid plate andguide cube (700) may be pulled out from the grid plate.

Guide cube (700) may include any suitable arrangement of guide holes andneed not be limited to only including central guide hole (716) as in theillustrated version. In some versions, guide cube (700) may include nineindividual guide holes arranged in three rows of three guide holes each.In some other versions, guide cube (700) may include one or more guideholes and guide cube (700) may be rotatable to provide for alternateguide hole orientations. In still other versions, guide cube (700)comprises slits or similar features instead of guide holes, to provide apassageway between opposing faces. It should be appreciated that someversions may include hinge members (702) that may be detachable fromguide cube (700) to permit rotation of guide cube (700) such that a faceother than face (708) is positioned proximally within the grid plate. Insuch versions, hinge members (702) may be re-attached along other facesof guide cube (700) besides just faces (704, 705). It is also noted thatguide cube (700) may be formed of a substantially rigid material, of anelastomeric material, and/or of any other suitable material, includingcombinations of materials. Still other suitable features,configurations, components, functionalities, operability, and variationsof guide cube (700) will be apparent to those of ordinary skill in theart in view of the teachings herein. It should also be understood thatany other guide cube described herein, and variations thereof, mayinclude one or more hinge members (702) if desired.

While several guide cubes have been discussed in detail above, it shouldbe understood that the components, features, configurations, and methodsof using the guide cubes discussed are not limited to the contextsprovided above. In particular, components, features, configurations, andmethods of use described in the context of one of the guide cubes may beincorporated into any of the other guide cubes. One merely exemplaryadditional feature that may be provided in any of the guide cubesdescribed herein is one or more ridges on one or more external faces ofthe cube. Such ridges may be substantially rigid, elastomeric, or haveany other suitable properties. Such ridges may provide a more secure fitbetween a cube and grid (e.g., reducing the likelihood that that theguide cube will undesirably fall out of the grid plate), may permit asingle cube to be inserted in different grids having differently sizedopenings, and/or may provide other results. Still other additional andalternative suitable components, features, configurations, and methodsof using the guide cubes will be apparent to those of ordinary skill inthe art in view of the teachings herein.

Versions of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

Versions of the devices disclosed herein can be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Versions may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, embodiments of the device may be disassembled, and anynumber of the particular pieces or parts of the device may beselectively replaced or removed in any combination. Upon cleaning and/orreplacement of particular parts, embodiments of the device may bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device mayutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

By way of example only, versions described herein may be sterilizedbefore and/or after a procedure. In one sterilization technique, thedevice is placed in a closed and sealed container, such as a plastic orTYVEK bag. The container and device may then be placed in a field ofradiation that can penetrate the container, such as gamma radiation,x-rays, or high-energy electrons. The radiation may kill bacteria on thedevice and in the container. The sterilized device may then be stored inthe sterile container for later use. A device may also be sterilizedusing any other technique known in the art, including but not limited tobeta or gamma radiation, ethylene oxide, or steam.

Having shown and described various versions in the present disclosure,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, versions, geometries, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

What is claimed is:
 1. A guide device for guiding a medical instrumentrelative to a patient, the guide device being usable with a first plateand a second plate, wherein the first plate has a plurality ofapertures, wherein the second plate and the first plate are adjustableto secure a portion of the patient, wherein the guide device isconfigured to be coupled with a selected one of the apertures of thefirst plate, the guide device comprising: a. a body defined by aplurality of surfaces, wherein the body comprises a proximal portion anda distal portion, wherein the body is comprised of a body materialhaving a first durometer; b. at least one passageway, wherein the atleast one passageway extends from the proximal portion through the bodyand to the distal portion, wherein the at least one passageway isconfigured to receive at least a portion of the medical instrument,wherein the at least one passageway is comprised of a passagewaymaterial having a second durometer, and wherein the second durometer isdifferent from the first durometer; and c. a pair of hinged memberscoupled to the body, each hinged member associated with at least onesurface of the body, wherein the pair of hinged members are operablyconfigured to interface with a surface of the first plate defining theselected one of the at least one apertures, and wherein each hingedmember comprises an angled member outwardly angled with respect to theat least one surface of the body in a naturally biased position, whereinthe angled member is connected to the at least one surface of the body,and wherein the angled member extends proximally past the proximalportion of the body.
 2. The guide device of claim 1, wherein the pair ofhinged members each comprise a distal end and a proximal end, whereinthe pair of hinged members are coupled to the body such that the distalends of each of the pair of hinged members are positioned adjacent thedistal portion of the body, and wherein the proximal ends of each of thepair of hinged members are positioned adjacent the proximal portion ofthe body.
 3. The guide device of claim 2, wherein the pair of hingedmembers each comprise an outer surface, wherein the outer surfaces faceaway from the body and are configured to interface with the first plate,wherein the outer surfaces comprise an elastomeric portion operable tocompress against the first plate.
 4. The guide device of claim 3,wherein the elastomeric material comprises a material selected from thegroup consisting of vulcanized thermosetting plastics, thermoplasticelastomers, natural rubber, synthetic rubber, and combinations thereof.5. The guide device of claim 3, wherein the guide device is insertablewithin the selected one of the at least one apertures of the firstplate, wherein the guide device further comprises a grounding structurespaced away from the proximal portion of the body and operativelyconfigured to prevent over-insertion of the guide device.
 6. The guidedevice of claim 5, wherein the pair of hinged members each comprise aprotruding portion at the proximal ends, wherein the protruding portionsare operably configured to contact an exterior surface of the firstplate to prevent over-insertion of the guide device.
 7. The guide deviceof claim 6, wherein the pair of hinged members each pivot to and from afirst position and a second position, wherein in the first position thepair of hinged members are oriented generally parallel to a pair ofadjacent outer faces of the body, and wherein in the second position thepair of hinged members are oriented generally non-parallel to theadjacent outer faces of the body.
 8. The guide device of claim 7,wherein the body further comprises recesses in the proximal portion,wherein the recesses are configured to receive the protruding portionsof the pair of hinged members when the pair of hinged members pivot tothe first position.
 9. The guide device of claim 1, wherein the hingedmembers are each coupled to the body by a respective living hinge. 10.The guide device of claim 9, wherein the hinged members are resilientlybiased to an outward position.
 11. A guide device insertable into anaperture of a grid plate for guiding a medical instrument relative to apatient, the guide device comprising: a. a body defined by a pluralityof faces, wherein the body comprises a proximal portion and a distalportion, wherein the body is comprised of a first material having afirst durometer, and wherein the body is further comprised of a secondmaterial having a second durometer, wherein the first durometer isdifferent from the second durometer; b. at least one passageway, whereinthe at least one passageway is comprised of the first material, whereinthe at least one passageway extends from the proximal portion throughthe body and to the distal portion, wherein the at least one passagewayis configured to receive at least a portion of the medical instrument;and c. a pair of hinged members coupled to the body, each hinged memberassociated with at least one face of the body, wherein the pair ofhinged members are operably configured to interface with a surface ofthe grid plate to provide a secure fit of the guide device within theaperture of the grid plate, wherein each hinged member comprises anangled member outwardly angled with respect to the at least one surfaceof the body in a naturally biased position, wherein the angled member isconnected to the at least one surface of the body, wherein the hingedmembers are resiliently biased to engage the grid plate, wherein eachangled member presents a narrowing taper from the proximal portion ofthe body to the distal portion of the body, and wherein the angledmember extends proximally past the proximal portion of the body.
 12. Theguide device of claim 11, wherein the pair of hinged members arepositionable in a first state and a second state, wherein in the firststate the pair of hinged members do not exert force on an interior wallof the grid plate defining the aperture, and wherein in the second statethe pair of hinged members do exert force on the interior wall of thegrid plate defining the aperture.
 13. The guide device of claim 12,wherein the pair of hinged members each comprise an outer surface,wherein the outer surfaces are configured to contact the interior wallof the first plate defining the aperture, wherein the outer surfacescomprise a compressible portion.
 14. The guide device of claim 13,wherein the at least one passageway is comprised of a rigid material,and wherein the body surrounding the rigid material is comprised of acompressible material.
 15. The guide device of claim 11, wherein thebody is formed using a two-step molding process wherein a first moldingprocess uses the first material and wherein a second molding processuses the second material.
 16. The guide device of claim 11, furthercomprising a grounding structure operatively configured to preventover-insertion of the guide device into the grid plate.
 17. The guidedevice of claim 16, wherein the pair of hinged members each comprise aprotruding portion, wherein the protruding portions are operablyconfigured to contact the grid plate to prevent over-insertion of theguide device.
 18. The guide device of claim 11, wherein the pair ofhinged members are selectively detachable from the body of the guidedevice, wherein the pair of hinged members are further configured toselectively attach to a plurality of faces of the body.
 19. A guidedevice for guiding a medical instrument relative to a patient, the guidedevice being usable with a first plate and a second plate, wherein thefirst plate has a plurality of apertures, wherein the second plate andthe first plate are adjustable to secure a portion of the patient,wherein the guide device is configured to be coupled with a selected oneof the apertures of the first plate, the guide device comprising: a. abody defined by at least one surface, wherein the body comprises aproximal portion and a distal portion, wherein the body is comprised ofa first material having a first durometer, and wherein the body isfurther comprised of a second material having a second durometer,wherein the first durometer is different from the second durometer; b.at least one passageway, wherein the at least one passageway iscomprised of the first material, wherein the at least one passagewayextends from the proximal portion through the body and to the distalportion, wherein the at least one passageway is configured to receive atleast a portion of the medical instrument; and c. a pair of hingedmembers coupled to the body, wherein the pair of hinged members areoperably configured to interface with a surface of the first platedefining the selected one of the at least one apertures, wherein eachhinged member originates from the distal portion and extends at an angleproximally, and wherein an angled member extends proximally past theproximal portion of the body.
 20. The guide device of claim 11, whereinthe pair of hinged members are positionable in a first state and asecond state, wherein in the first state the pair of hinged members donot exert force on an interior wall of the grid plate defining theselected one of the apertures, and wherein in the second state the pairof hinged members do exert force on the interior wall of the first platedefining the selected one of the apertures.